For Patients

Iressa (gefitinib) Tablets is a chemotherapy medication used to treat non-small cell lung cancer. It is available in generic form. Common side effects of Iressa include nausea, vomiting, loss of appetite, diarrhea, rash, dryness, itching, acne, and weakness.

The recommended daily dose of Iressa is 250 mg. Iressa must be administered under a doctor's supervision. Warfarin, Rifadin, Dilantin, Nizoral, Sporanox, and stomach acid reducers may interact with Iressa. Tell your doctor all medications you take. Before taking Iressa tell your doctor if you have decreased liver function. Do not take Iressa if you are pregnant or breastfeeding.

Our Iressa (gefitinib) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Persistent nausea, vomiting, diarrhea, or loss of appetite may result in a serious loss of body water (dehydration) and kidney problems. Contact your doctor promptly if you notice any symptoms of dehydration, such as: unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, dizziness/lightheadedness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding (coughing up blood, blood in urine), eye irritation/pain, swelling of the ankles/feet.

If you have persistent diarrhea or skin rashes contact your doctor. Your doctor may temporarily stop gefitinib (for up to 14 days) which may help reverse those side effects. Treatment is then resumed with the same dosage.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: severe rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Table 4 provides drug-related adverse events with an incidence of ≥ 5% by
CTC grade for the patients who received the 250 mg/day dose of IRESSA (getfitinib) monotherapy
for treatment of NSCLC. Only 2% of patients stopped therapy due to an adverse
drug reaction (ADR). The onset of these ADRs occurred within the first month
of therapy.

Table 3 - Drug-Related Adverse Events With an Incidence of
≥ 5% in either 250 mg or 500 mg Dose Group

Other adverse events reported at an incidence of <5% in patients who received
either 250 mg or 500 mg as monotherapy for treatment of NSCLC (along with their
frequency at the 250 mg recommended dose) include the following: peripheral edema (2%), amblyopia (2%), dyspnea (2%), conjunctivitis (1%), vesiculobullous
rash (1%), and mouth ulceration (1%).

Interstitial Lung Disease

Cases of interstitial lung disease (ILD) have been observed in patients receiving
IRESSA (getfitinib) at an overall incidence of about 1%. Approximately 1/3 of the cases have
been fatal. The reported incidence of ILD was about 2% in the Japanese post-marketing
experience, about 0.3% in approximately 23,000 patients treated with IRESSA (getfitinib)
in a US expanded access program and about 1% in the studies of first-line use
in NSCLC (but with similar rates in both treatment and placebo groups). Reports
have described the adverse event as interstitial pneumonia, pneumonitis and
alveolitis. Patients often present with the acute onset of dyspnea, sometimes
associated with cough or low-grade fever, often becoming severe within a short
time and requiring hospitalization. ILD has occurred in patients who have received
prior radiation therapy (31% of reported cases), prior chemotherapy (57% of
reported patients), and no previous therapy (12% of reported cases). Patients
with concurrent idiopathic pulmonary fibrosis whose condition worsens while
receiving IRESSA (getfitinib) have been observed to have an increased mortality compared
to those without concurrent idiopathic pulmonary fibrosis.

In the event of acute onset or worsening of pulmonary symptoms (dyspnea, cough,
fever), IRESSA (getfitinib) therapy should be interrupted and a prompt investigation of these
symptoms should occur. If interstitial lung disease is confirmed, IRESSA (getfitinib) should
be discontinued and the patient treated appropriately (see WARNINGS
- Pulmonary Toxicity, PRECAUTIONS - INFORMATION FOR
PATIENTSand DOSAGE AND ADMINISTRATION
- Dosage Adjustment sections).

In patients receiving IRESSA (getfitinib) therapy, there were reports of eye pain and corneal
erosion/ulcer, sometimes in association with aberrant eyelash growth (see PRECAUTIONS
- INFORMATION FOR PATIENTSsection). Hemorrhage,
such as epistaxis and hematuria have been reported in patients receiving IRESSA (getfitinib) .
There were also rare reports of pancreatitis and very rare reports of corneal
membrane sloughing, ocular ischemia/hemorrhage, toxic epidermal necrolysis,
erythema multiforme, and allergic reactions, including angioedema and urticaria.

Data from non-clinical (in vitro and in vivo) studies indicate that
gefitinib has the potential to inhibit the cardiac action potential repolarization
process (eg, QT interval). The clinical relevance of these findings is unknown.